Statins take on COPD: could a heart drug curb lung Flare-Ups?
NCT ID NCT04789057
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether atorvastatin, a widely used cholesterol medication, can reduce inflammation and prevent flare-ups in smokers with chronic obstructive pulmonary disease (COPD). About 460 participants will receive either atorvastatin or a placebo for several months. The goal is to see if the drug can lower the rate of COPD exacerbations and possibly reduce cancer risk, while also identifying which patients might benefit most.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 460 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject has signed Informed Consent Form and is able to understand the purpose and procedures required for the study and is willing to participate in the study. 2. Subject \[male or female\] is aged 40 years and older. 3. Subject is able to understand and comply with the protocol requirements and instructions and is likely to complete the study as planned. 4. Patients with stable COPD with persistent airflow limitation (stable COPD (post-bronchodilator FEV1\<80% of the predicted normal and post-bronchodilator FEV1/FVC\<0,70 at visit 1.) Stage II- IV) and with moderate to very severe airflow limitation according to GOLD guidelines. 5. At least two moderate/severe COPD exacerbations, or at least one leading to hospitalization or ICU admission within 12 months, preceding screening visit. 6. Current or ex-smokers who have a smoking history of at least 10 pack years. Exclusion Criteria: 1. Contraindication to statin therapy included but not limited to: known poliomyelitis, motor neuron disease, cranial or temporal arteritis, stroke or myopathy. 2. Statin use within the last 3 months prior to study start. 3. Prior diagnosis of statin induced myopathy or hypersensitivity reaction to another HMG-CoA-reductase inhibitor. 4. Using e-cigarettes or I IQOS tobacco heating system. 5. Pregnant or nursing (lactating) women. 6. Women of child bearing potential, unless they are using effective method of contraception during dosing of study treatment. 7. Patient with a clinically significant abnormality at visit 1 in investigator opinion. 8. Patients with a clinically relevant laboratory abnormality at visit 1 in investigator opinion. 9. Patients with a history of malignancy of any organ system (including lung cancer). 10. Patients unable to perform acceptable spirometry and lung volumes procedures. 11. Patients who had a COPD exacerbations that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to visit 1. 12. Patients who have had a respiratory tract infection within 4 weeks prior to visit1. 13. Patients requiring oxygen therapy (\>15hr/day) on a daily basis for chronic hypoxemia. 14. Patients with a history of asthma or onset of symptoms prior to age 40 years 15. Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, tuberculosis). 16. Patients with primary bronchiectasis. 17. Patients with a diagnosis of α-1 antitrypsin deficiency (AATD). 18. Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation. 19. Active abuse of drugs or alcohol, poor compliance anticipated. 20. Use concomitant medications that are known to interact with atorvastatin: warfarin and other coumarin (vitamin K antagonists) anticoagulants, cyclosporin, gemfibrozil or other non or selective nonsteroidal anti-inflammatory drugs, proton pump inhibitors (PPIs) used by last 6 months. 21. Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study. 22. Use of other investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening visit. 23. Those unable in the opinion of the Investigator to comply fully with the study requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Medical University Hospital
Bialystok, 15-540, Poland
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Other studies related to the condition(s) this trial covers.
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